Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005646850

FEI Number

3005646850

Entity Name

Jabil Inc.

City/State/Country

AUBURN HILLS, MI, US

Establishment Address

3800 GIDDINGS RD., AUBURN HILLS, MI 48326, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Jabil Inc. (Owner Number: 9074019)

Owner / Operator Contact Address

10800 Roosevelt Blvd., Saint Petersburg, FL 33716, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

STERRAD 100NX Sterilizer with ALLClear Technology and ULTRA GI Cycle (10104-009,10104-010) AEROFLEX Automatic Endoscope Reprocessor with AUTOSURE MRC Monitor STERRAD NX Sterilization System with ALLClear Technology (10133, 10033-004) Ulthera System (UC-1 Control Unit PRIME) STERRAD 100S (10101) Stryker F1 Charger Module Megadyne Connect Cable 2.1m Megadyne Connect Cable 1m Megadyne Smoke Evacuator Sterrad 100NX Sterilizer with Duo Cycle 100NX with Express Cycle Ethicon Megadyne Electrosurgical Generator Chemical Sterilizer 100NX Harmonic® 1100 Shears Evotech STERRAD 100NX Sterilization System with ALLClear Technology (10144,10104ACSW, 10104-005,10104-006, 10104-007, 10104-008) Ulthera System Ulthera

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MLR	Sterilizer, Chemical	General Hospital	Class 2	880.6860	2024-12-17
FEB	Accessories, Cleaning, For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2019-05-07
MLR	Sterilizer, Chemical	General Hospital	Class 2	880.6860	2024-12-17
HGI	Electrocautery, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.4120	2018-02-20
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2018-02-20
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2018-02-20
MLR	Sterilizer, Chemical	General Hospital	Class 2	880.6860	2017-12-05
OHV	Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption	General, Plastic Surgery	Class 2	878.4590	2024-05-01
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2024-05-01
FLF	Sterilizer, Ethylene-Oxide Gas	General Hospital	Class 2	880.6860	2025-01-14
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2024-12-17
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2018-08-26
FYD	Apparatus, Exhaust, Surgical	General, Plastic Surgery	Class 2	878.5070	2020-09-16
MLR	Sterilizer, Chemical	General Hospital	Class 2	880.6860	2013-02-27
MLR	Sterilizer, Chemical	General Hospital	Class 2	880.6860	2013-01-14
MLR	Sterilizer, Chemical	General Hospital	Class 2	880.6860	2017-11-20
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2020-09-16
MLR	Sterilizer, Chemical	General Hospital	Class 2	880.6860	2012-11-16
FXZ	Helmet, Surgical	General, Plastic Surgery	Class 1	878.4040	2020-06-09
MLR	Sterilizer, Chemical	General Hospital	Class 2	880.6860	2016-12-12
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-10-24
HGI	Electrocautery, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.4120	2020-09-01
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2020-09-01
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2020-09-01
FEB	Accessories, Cleaning, For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2013-01-14
MLR	Sterilizer, Chemical	General Hospital	Class 2	880.6860	2016-12-12
MLR	Sterilizer, Chemical	General Hospital	Class 2	880.6860	2024-12-17
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2014-11-03
OHV	Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption	General, Plastic Surgery	Class 2	878.4590	2014-11-03

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Jabil Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3015410662	Jabil Inc. (Wilson Drive)	W Chester, PA, US
3011246727	Jabil Circuit Sdn. Bhd.	Bayan Lepas Pulau Pinang, MY
3003512059	NYPRO DR, LLC (Bldg 11)	Haina San Cristobal, DO
3004730544	NYPRO DR, LLC (Building 52)	Haina San Cristobal, DO
1424235	Nypro Inc. (Chicago)	GURNEE, IL, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02
K192128	Sutter Medizintechnik GmbH	Sutter Arrowtip Monopolar Electrodes	2019-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0043-2014	Advanced Sterilization Products	2	STERRAD 200 Sterilizer (Single Door), Part Number: 10201. STERRAD 200 Sterilizer (Double Door), Part Number: 10202. The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
Z-0044-2014	Advanced Sterilization Products	2	STERRAD 100NX Cassettes The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
Z-0008-2013	Gynex Corporation	2	Sterile, single-use, disposable electrosurgical electrode holder. It connects the electrode to the foot activated electric generator. Label reads in part "*GYNEX* Electrode Handpiece, Foot Activated* Manufactured for GYNEX*" Gynex catalog number: 950 (Gynex REF 950, Electrode Handpiece) It connects the electrode to the food activated electric generator. Electrodes are used in gynecological procedures, in a physician's office, for cutting to remove tissue and coagulation to control bleeding by the use of high frequency current.
Z-0332-2022	Covidien Llc	U	Covidien Sonicision Battery Charger-intended to charge the Sonicision Reusable Battery Pack and to provide information on the battery charging progress and battery pack status Item Code: CBCA
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826

Similar Registrations

Registration Number	Establishment Name	Location
3015207155	Zimmer (Shanghai) Medical International Trading Co., Ltd.	Shanghai, CN
3003950207	STERIS Corporation	Mentor, OH, US
3016075971	Plasmapp Co., Ltd.	Asan-si Chungnam, KR
3005899764	STERIS MEXICO, S. de R.L. de C.V.	GUADALUPE Nuevo Leon, MX
2084725	ADVANCED STERILIZATION PRODUCTS	Irvine, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005646850. Last updated year: 2026. Please use registration number 3005646850 when referencing this establishment in official correspondence.